Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation

NCT06273163 | Terminated

• 1 other identifier: STU-2023-1168
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (\~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance.

Conditions

Obesity

Keywords

Glucagon-Like Peptide-1 Receptor Agonists; Body Weight Maintenance

Outcome Measures

Primary Outcomes (2)

• Intervention Adherence

  Adherence will be measured using the Perceived Behavior subscale (6-items) from the validated Treatment Adherence Perception Questionnaire (TAPQ).

  4-months

• Intervention Satisfaction

  The Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to measure satisfaction, and be adapted for the interventions understudy. Responses are provided on a 7-point Likert scale ranging from extremely satisfied to extremely dissatisfied. Scores are then transformed to a 0-100 scale with a higher score indicating greater treatment satisfaction.

  4-months

Secondary Outcomes (2)

• Percent weight loss maintained

  4-months

• Diet quality

  4-months

Other Outcomes (1)

• Incremental cost effective ratio (ICER)

  4-months

Study Arms (3)

Medically tailored meals

EXPERIMENTAL

Participants will receive 10 medically tailored meals per week (40 meals per month) for four-months.

Other: Medically tailored meals; Other: Usual care

Noom®

EXPERIMENTAL

Participants will receive a paid Noom® subscription for four-months. Noom® is a subscription-based mobile application that provides food intake and exercise tracking and uses principles from psychology to motivate behavior change.

Behavioral: Noom®; Other: Usual care

Usual care

PLACEBO COMPARATOR

Participants will receive usual care from their provider.

Other: Usual care

Interventions

Medically tailored meals OTHER

Medically tailored meals are nutritious meals formulated for weight wellness.

Medically tailored meals

Noom® BEHAVIORAL

Noom® is a subscription-based mobile application used to support healthy eating and exercise behavior change.

Noom®

Usual care OTHER

Care is provided at the discretion of the individual provider (e.g., usual care).

Medically tailored meals; Noom®; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• ability to read, write, and speak English;
• ability to provide informed consent;
• greater than 10% GLP-1 Receptor Agonist induced weight loss
• less than 30-days since GLP-1 Receptor Agonist cessation;
• willing to participate.

You may not qualify if:

• major psychiatric illness or substance misuse that could impair ability to participate;
• presence of a medical condition or dietary restriction precluding eating study meals or weight loss (e.g., medical condition requiring liquid diet, pregnancy, eating disorder);
• participation in a study or program involving medically tailored meals or Noom® within the past 12-months.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• UT Southwestern Nutrition Obesity Research Center: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kelseanna Hollis-Hansen, PhD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Complete masking is not feasible given the nature of the interventions - the program coordinator and participants will know if the participant receives home delivered medically tailored meals, a smart device application subscription, or usual care. The care provider will not be told the participants group assignment, but the participant may reveal it themselves in discussions with the provider.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized repeated measures between-subjects design

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: March 5, 2024
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (1)